EMA greenlights Novo’s degludec

22.10.2012 - The EMA has paved the road to EU approval for Novo Nordisk’s long-acting insulin Tresiba – set to become a competitor of Sanofi’s diabetes medicine Lantus.

On October 19, the European regulator said yes to the ultra long-acting insulin analogon Tresiba (insulin degludec) which had outcompeted Sanofi’s diabetes blockbuster Lantus (insulin glargine) in a Phase III head-to-head trial published this spring (Lancet). In the trial, the rate of nocturnal confirmed hypoglycaemia was 25% lower with degludec than with glargine.

Analysts estimated that Novo Nordisk’s diabetes medicine could hit peak sales of €2-3bn annually in the global €35bn diabetes market. The drug, which is also slated for FDA panel review in early November, could take a big slice of the cake in a growing diabetes market. According to market estimate, the market could reach US$58bn by 2018, according to Standard & Poor.

Novo Nordisk’s degludec, which is injected subcutaneously trice a week, lasts up to 40 hours, unlike the 18 to 26 hours provided by current marketed long-acting insulins such as insulin glargine and insulin detemir, which is also marketed by the Danes. Degludec has one single amino acid deleted from the human form of insulin, and is conjugated to hexadecanedioic acid via gamma-L-glutamyl spacer at the amino acid lysine at position B29

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